The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

Fluarix Tetra has been approved for use in children aged six months and above.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

The companies will work together on developing regenerative medicine therapies for heart failure.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.

The company is voluntarily recalling one lot of Acyclovir Tablet due to packaging that may contain a different product.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

The companies will partner to further immuno-oncology research using humanized mice.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

The company has made an equipment donation to Purdue University's continuous manufacturing research program.

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

CPhI North America 2018, taking place Apr. 24-26 in Philadelphia, PA, has announced Dr. Bertalan Mesko as its first keynote speaker.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

The agency met to discuss its new temporary and permanent premises in Amsterdam.